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FOLFOX-4 Regimen or Single-agent Gemcitabine as First-line Chemotherapy in Advanced Biliary Tract Cancer

Novarino, Anna Maria Teresa, MD*; Satolli, Maria Antonietta, PhD*; Chiappino, Isabella, MD*; Giacobino, Alice, MD*; Napoletano, Raffaella, MD*; Ceccarelli, Manuela, MD†,‡; Ciccone, Gianni, MD; Schena, Marina, MD*; Bertetto, Oscar, MD*; Ciuffreda, Libero, MD*

American Journal of Clinical Oncology: October 2013 - Volume 36 - Issue 5 - p 466–471
doi: 10.1097/COC.0b013e31825691c3
Original Articles: Gastrointestinal

Objectives: We conducted a retrospective cohort study to compare 2 different chemotherapy regimens for advanced biliary tract cancer (BTC).

Methods: Records of patients consecutively treated in our institution for advanced BTC from 2001 to 2006 were retrieved. Chemotherapy treatment with FOLFOX-4 regimen was routinely offered as first option; gemcitabine (GEM) as single agent was proposed as an alternative option to patients who refused central venous catheter implantation. Toxicity, overall response rate, progression-free survival (PFS), and overall survival (OS) obtained with the 2 treatments were evaluated.

Results: Twenty-two patients were treated with FOLFOX-4, whereas 18 patients received GEM. In the FOLFOX-4 group, the overall response rate was 13.6% (95% confidence interval [CI], 4.7-33.3), with 1 complete response and 2 partial responses, and 54.5% (95% CI, 34.7-73.1) of disease control rate (complete response+partial response+stable disease). Median OS was 14.1 months (95% CI, 9.1-18.8) and median PFS 5.44 months (95% CI, 3.2-6.3). In the GEM group, we observed no objective response, whereas 27.7% (95% CI, 12.5-50.9) obtained disease control. Median OS was 8.3 months (95% CI, 4.7-12.9) and median PFS 3.9 months (95% CI, 2.2-5.4). Toxicity, mainly hematological, was acceptable for both treatments. On a multivariable Cox model including a propensity score, only the performance status and chemotherapy regimen were confirmed as strong predictors of OS, with an hazard ratio of 0.49 (95% CI, 0.24-0.99) in favor of FOLFOX-4.

Conclusions: The combination chemotherapy with oxaliplatin and 5-fluorouracil is well tolerated and seems to provide prolonged survival than GEM alone in advanced BTC treatment, but further randomized trials are warranted.

*Department of Oncology

Unit of Cancer Epidemiology and CPO Piemonte, San Giovanni Battista Hospital

Department of Public Health and Microbiology, University of Torino, Torino, Italy

The authors declare no conflicts of interest.

Reprints: Marina Schena, MD, Department of Oncology, Centro Oncologico ed Ematologico Subalpino, Azienda Ospedaliera San Giovanni Battista, Corso Bramante 88, 10126 Torino, Italy. E-mail:

© 2013 by Lippincott Williams & Wilkins, Inc